Himanshu Saini July 26, 2025
Sunscreen is one of the most important skincare products today. People use it to protect their skin from the sun and prevent problems like sunburn, early ageing, and even skin cancer. Because of this, many cosmetic brands are now adding SPF (Sun Protection Factor) to their products, like creams, lotions, and makeup.
But selling sunscreen or SPF products is not as simple as just adding a label that says “SPF 30.” These products must follow strict rules and regulations, especially when it comes to what ingredients are used, how well they work, and how the packaging is labelled.
If your brand is planning to launch your sunscreen brand or SPF cosmetics, it’s very important to understand the rules and how to create correct, clear labels. In this blog, we’ll explain sunscreen compliance in simple terms and share easy tips to help your brand stay safe, legal, and trustworthy.
Why Sunscreen is More Than Just a Cosmetic?
Sunscreens are not just cosmetic products; in many countries, they are considered over-the-counter (OTC) drugs or regulated therapeutic goods.
This is because they actively protect the skin from harmful ultraviolet (UV) radiation, which can cause sunburn, skin ageing, and increase the risk of skin cancer. Therefore, these products must be safe, effective, and properly labelled.
Different regions have different regulations. For example:
- In the U.S., sunscreens are regulated by the FDA (Food and Drug Administration).
- In the EU, they are regulated under the EU Cosmetics Regulation (EC) No. 1223/2009.
- In Australia, the Therapeutic Goods Administration (TGA) oversees sunscreens.
- In India, they fall under CDSCO and BIS regulations.
Each of these authorities requires brands to follow specific testing, safety standards, and accurate SPF labelling.
Common Terms Found on Sunscreen Labels
Before diving into compliance tips, it helps to understand the common sunscreen terms that often appear on labels:
- SPF (Sun Protection Factor) – Measures protection against UVB rays (responsible for sunburn).
- Broad-Spectrum – Indicates protection against both UVA (ageing) and UVB (burning) rays.
- Water Resistant – Product maintains SPF protection after water exposure (typically 40 or 80 minutes).
- PA Rating – Used mostly in Asian countries, it shows the level of UVA protection (e.g., PA+, PA+++).
- UVA Seal – In Europe, this seal confirms a minimum 1/3 UVA to UVB protection ratio.
Understanding and using these terms accurately is essential for both legal compliance and consumer trust.
Compliance Tips for Sunscreen and SPF Products
Here are some simple yet important compliance tips to help your cosmetic brand stay on the right side of regulations:
1. Use Approved UV Filters Only
Each region has a list of UV filters (active ingredients) that are legally permitted for sunscreen use. For example:
- The U.S. FDA allows only 16 active UV filters.
- The EU has 29 approved UV filters.
- India follows BIS and CDSCO guidelines.
Before formulating your product, always check the latest list of approved ingredients for your market.
2. Conduct Proper SPF Testing
You cannot just claim a product is “SPF 30” without proof. Your product must be tested according to internationally accepted methods, such as:
- ISO 24444 – for SPF (UVB) testing.
- ISO 24443 – for UVA and broad-spectrum protection.
- FDA Final Rule (U.S.) – for SPF and water resistance testing.
Always test your finished product through a certified, third-party lab. Keep documentation ready for inspection or certification.
3. Label All Claims Honestly and Clearly
Misleading labels are one of the biggest compliance violations. Avoid making unproven claims like:
- “All-day protection”
- “Instant sunblock”
- “100% waterproof”
Stick to regulated terminology, and ensure that claims are backed by evidence, especially when using terms like “broad-spectrum” or “PA+++”.
4. Include Mandatory Warnings and Directions
Most countries require sunscreens to carry safety warnings, such as:
- “Reapply every 2 hours”
- “Limit time in the sun”
- “For external use only”
- “Avoid contact with eyes”
These instructions help protect consumers and reduce legal risks for your brand.
5. Keep Packaging and Fonts Clear
Use readable fonts and clear design, and use custom packaging to highlight:
- SPF value
- Broad-spectrum claim
- Expiry date
- Usage instructions
- Net quantity
- Ingredients list (INCI format)
Avoid tiny or confusing fonts. Ensure compliance with labelling rules specific to your region (like font size minimums or placement requirements).
6. Don’t Skip Stability & Shelf-Life Testing
Since sunscreens are often exposed to heat and sun, they must be tested for stability and shelf life. This means your SPF rating must hold up for the entire stated duration (typically 24–36 months). Expiry dates are not optional, and they must be included on the label.
7. Follow Local Import/Export Laws
If you’re selling internationally, remember: Each country has different rules.
A product compliant in India may not meet FDA or EU standards. Ensure that your formulas, claims, and documents align with the destination country’s regulations. This is especially important for online cosmetic businesses that ship worldwide.
Best Practices for Labeling Sunscreen Products
Here’s a checklist to help you create sunscreen labels that are both compliant and customer-friendly:
| Label Element | Why it Matters |
| SPF Value (e.g. SPF 30) | Required to indicate sunburn protection level |
| Broad-Spectrum | Shows protection from both UVA and UVB rays |
| Water Resistance (if any) | Must be backed by lab tests (40 or 80 minutes |
| Usage Directions | Helps consumers apply it correctly |
| Warnings | Prevents misuse and supports legal protection |
| Ingredient List (INCI) | Required for transparency and allergy information |
| Expiry Date | Mandatory for product safety and shelf-life |
| Manufacturer Details | Includes name, address, and country of manufacture |
| Net Content | Shows how much product is in the package |
Risks of Failing to Meet Sunscreen Compliance
If your sunscreen or SPF product is non-compliant, you could face:
- Product recalls
- Fines and penalties
- Import/export bans
- Damage to your brand reputation
- Customer lawsuits in extreme cases
It helps you earn customer trust and get credibility for your sunscreen brand. A compliant product shows that your brand is serious about safety, quality, and care.
Final Thoughts
In the skincare world, sunscreen is a must-have, but it’s also one of the most heavily regulated categories. As a cosmetic brand, your credibility depends on getting it right.
When you take the time to follow sunscreen compliance rules and create clear, honest labels, you’re not just following laws; you’re protecting your customers and building a brand that people can trust.
If you’re planning to succeed as a sunscreen brand, we would recommend you consider the top sunscreen trends in the market.
FAQs
Q. Is sunscreen considered a cosmetic or a drug?
Ans. It depends on the country. In the United States, sunscreen is classified as an over-the-counter (OTC) drug and regulated by the FDA. In the EU and India, it is considered a cosmetic product but still must meet strict testing and labelling requirements.
Q. Can I add SPF to my cosmetic product without testing it?
Ans. No. You must test your final product through certified labs to verify the SPF level. It’s not enough to rely on the SPF value of raw ingredients.
Q. What is the difference between SPF and broad-spectrum?
Ans. SPF protects mainly against UVB rays (which cause sunburn), while broad-spectrum means the product also protects against UVA rays (which cause skin ageing). Both are important for full sun protection.
Q. Can I say “waterproof” on my sunscreen label?
Ans. No. Terms like “waterproof” or “sweatproof” are not allowed in many countries, including the U.S. Instead, use “water resistant (40 or 80 minutes)” if your product has passed the required tests.
Q. How often should sunscreen be reapplied according to labelling rules?
Ans. Most regulations recommend including directions to reapply every 2 hours, especially after swimming, sweating, or towel drying.
